What is the importance of GxP compliance?
GxP compliance is a series of regulatory and quality guidelines created to ensure that life science products are safe and that the integrity of supporting data is upheld and maintained. Compliance with GxP helps to ensure the traceability, accountability, and integrity of the data supporting life science products and services.
GxP compliance is important to maintain the process quality throughout each stage of product development including manufacturing, control, storage, and distribution.
There are also product-specific requirements that life science organizations are required to follow, depending on the type of product and the country in which products are being sold.
With the fundamental purpose of GxP requirements being to ensure that food and medical products are safe for consumers, they are initially determined by the Food and Drug Administration (FDA), which also oversees ongoing regulation.
What does GxP stand for?
The FDA identifies compliance-related activities as:
These good practices are related to a range of compliance activities, including:
Good Manufacturing Practices (GMP) — GMP addresses cleanliness and hygiene, valid process usage, handling complaints, record keeping, and personnel qualifications. GMP takes required and proactive measures to ensure the safety and efficacy of products. GMP guidelines also allow manufacturers to easily understand how to best implement them in their respective specific environments.
Good Laboratory Practices (GLP) — GLP mandates targets to ensure the repeatability, uniformity, reliability, quality, and integrity of human and animal health products through safety tests in research laboratories. The key principles of GLP — tested under a certified QMS system — include risk management, organization, and responsibilities.
Good Clinical Practices (GCP) — GCP is a global standard monitored by the International Conference on Harmonization (ICH) and focuses on the morality of clinical trials. The ICH stipulates that the interests of corporations are not prioritized over human life in clinical trials when using human subjects. ICH also assures this approach is followed when conducting clinical trials.
Read our GXP Compliance Guide